Catheters Having Laterally Deployable Members
The prior art has included a variety of intravascular catheters that have laterally deployable members (e.g., wires, needles, other catheters, probes, etc.) which advance or extend laterally from the body of the catheter. In some applications, these catheters are used to direct a laterally deployable member into a furcation, side branch or other angulation vessel. In other applications, the laterally deployable members are caused to penetrate through tissue or other matter within the body to reach some desired target location.
U.S. Pat. No. 4,774,949 (Fogarty) describes a deflector guiding catheter having a lumen that extends through the catheter and terminates distally in a side outlet opening. As the lumen approaches the side outlet opening, it smoothly curves from axial to angular orientation so as to deflect a member (e.g., a guidewire or another catheter) out of the side outlet opening such that the member may then advance laterally from the catheter body. In applications where it is desired to deflect the member into a side branch or other angulation vessel, the side outlet port is positioned in registry with the mouth of the side branch or angulation vessel. The shape and curvature of the distal portion of the lumen is designed to support the laterally deployable member during advancement and to prevent backup movement of the laterally deployable member during placement, dilatation and/or extrusion.
U.S. Pat. Nos. 5,830,222 (Makower), U.S. Pat. No. 6,068,638 (Makower), U.S. Pat. No. 6,159,225 (Makower), U.S. Pat. No. 6,190,353 (Makower, et al.), U.S. Pat. No. 6,283,951 (Flaherty, et al.), U.S. Pat. No. 6,375,615 (Flaherty, et al.), U.S. Pat. No. 6,508,824 (Flaherty, et al.), U.S. Pat. No. 6,544,230 (Flaherty, et al.), U.S. Pat. No. 6,655,386 (Makower et al.), U.S. Pat. No. 6,579,311 (Makower), U.S. Pat. No. 6,602,241 (Makower, et al.), U.S. Pat. No. 6,655,386 (Makower, et al.), U.S. Pat. No. 6,660,024 (Flaherty, et al.), U.S. Pat. No. 6,685,648 (Flaherty, et al.), U.S. Pat. No. 6,709,444 (Makower), U.S. Pat. No. 6,726,677 (Flaherty, et al.) and U.S. Pat. No. 6,746,464 (Makower) describe a variety of catheter devices having laterally deployable tissue penetrating members (e.g., wires, needles, energy emitting penetrators, cannulae, etc.). These catheter devices are positionable within natural or man made body passages (e.g., blood vessel lumens, other lumens, passages, spaces, cul-de-sacs, tracts, subintimal spaces, etc.) and the laterally deployable tissue penetrating members are advanced to target locations outside of the passage in which the catheter is positioned. These types of catheter devices are useable in many types of interventions, including the delivery of substances (e.g., drugs, biologics, cells, genes, contrast media or other diagnostic or therapeutic substances), articles or devices to target locations within the body, passage of guidewires and/or catheters for accessing target locations, bypassing of obstructions, re-entry into a true lumen of a blood vessel from a subintimal space, etc.
Treatment of Chronic Total Occlusions
One particular example of a procedure in which catheter devices of the above-described type have been used is in the bypassing of chronic total occlusions, or CTOs. A CTO is a complete or nearly complete blockage in an artery. In many CTO cases, a guidewie can be advanced around the obstructive lesion, but this typically results in the distal portion of the guidewire penetrating or dissecting into the artery wall such that a distal portion of the guidewire becomes entrapped in a subintimal space (e.g., a dead-end channel created by advancement of the guidwire within the artery wall next to the obstruction). When such subintimal entrapment of the guidewire occurs, it is necessary to cause the distal end of that guidewire, or alternatively a separate guidewire, to reenter the true lumen of the artery downstream of the obstruction.
Techniques for guiding re-entry of subintimally entrapped guidewires into the true lumen of an artery have been known for quite some time. Prior to 1990, subintimal passage of a CTO was typically performed only if the guidewire had accidentally entered the subintimal space.
In 1990, Bolia, et al. reported a catheter-based technique for intentional extraluminal recanalization of a femoral-popliteal CTO. Specifically, Bolia, et al. reported that in cases where the guidewire failed to naturally re-enter the true lumen distal to the obstruction, a curved catheter could be inserted into the subintimal space and used to guide the distal end of the guidewire back into the true lumen. Bolia et al., Percutaneous Transluminal Angioplasty of Occlusions of the Femoral and Popliteal Arteries by Subintimal Dissection, Cardiovasc. Intervent. Radiol. 13:357-63 (1990).
In 1994, Reekers, et al. reported work conducted between 1990 and 1992 wherein a custom made 5 French catheter having a tip angle of 30, 50 or 70 degrees was inserted into the subintimal space and used to guide reentry of the guidewire into the true lumen of the artery distal to the CTO. Reekers, J.A., Percutaneous Intentional Extraluminal Recanalisation of the Femoropopliteal Artery, Eur. J. Vasc. Surg., 8:723-28 (1994).
In 1995, Kimura et all. reported that the use of intravascular ultrasound (IVUA) could be helpful in navigating subintimally entrapped guidewires back into the true lumen of the artery. Kimura, B.J., et al., Subintimal Wire Position During Angioplasty Of A Chronic Total Coronary Occlusion: Detection And Subsequent Procedural Guidance By Intravascular Ultrasound, Cathet. Cardiovasc. Diagn., 35(3), 262-65 (July 1995).
Also in 1995, a initial United States patent application was filed describing and claiming catheters that had laterally deployable members (e.g., needles or cannulae) for penetrating from a body passage in which the catheter is positioned (e.g., a blood vessel lumen, body cavity or other passage or space such as a subintimal tract created by a guidewire passing a CTO) to some target location outside of that body passage. In some embodiments, these catheters included orientation elements such as on-board imaging devices (e.g., intravascular ultrasound imaging) and/or imageable markers that could be used by the operator to determine the rotational orientation of the catheter in situ such that the operator could adjust the rotational orientation of the catheter as needed before deployment of the laterally deployable member, thereby facilitating subsequent extension or advancement of the laterally deployable member into a desired target location (e.g., back into the true lumen of the blood vessel) rather than to some other undesired location. A number of United States and non-United States patents have issued from or claim priority to this originally filed 1995 patent application, including but not limited to U.S. Pat. No. 5,830,222 (Makower), U.S. Pat. No. 6,068,638 (Makower), U.S. Pat. No. 6,746,464 (Makower), U.S. Pat. No. 6,231,587 (Makower), U.S. Pat. No. 6,190,353 (Makower et al.), U.S. Pat. No. 6,655,386 (Makower et al.), the entire disclosures of which are expressly incorporated herein by reference.
Catheters useable for guiding reentry of subintimally entrapped guidewires are being developed and/or sold commercially. For example, the Outback™ catheter (Lumend Inc. of Redwood City, Calif.) is a relatively simple catheter that has a laterally deployable needle. The catheter is inserted into the subintimal space with the needle in its retracted position. Thereafter, the laterally deployable needle is advanced from the subintimal space into the true lumen. A guidewire is then advanced through the lumen of the needle into the true lumen. The Outback™ catheter also includes an imageable marker that is configured to indicate the direction in which the needle will advance so that the operator may adjust the rotational orientation of the catheter in situ to facilitate subsequent advancement of the needle into the true lumen rather than to some other undesired location, substantially as described in various U.S. patents including U.S. Pat. No. 6,655,386 (Makower et al.).
The Pioneer™ catheter (Medtronic Vascular, Inc. of Santa Rosa, Calif.) is also a catheter that has a laterally deployable needle that may be used to penetrate from the subintimal space into the true lumen such that a guidewire may then be advanced through the needle and into the true lumen of the artery. Additionally, the Pioneer™ catheter incorporates an on-board IVUS device which provides an image that may be used by the operator to adjust the placement and rotational orientation of the catheter in situ to facilitate subsequent advancement of the needle into the true lumen rather than to some other undesired location, substantially as described in various U.S. patents including U.S. Pat. No. 6,655,386 (Makower et al.). The needle of the Pioneer™ catheter is elastic and biased to a curved configuration. A substantially rigid needle housing is mounted within the catheter body and the distal portion of the needle resides within such needle housing while in its retracted position. The curvature of the needle mates with the curvature of the needle housing, thereby causing the needle to be rotationally constrained in its intended rotational orientation. Also, the needle housing is radiographically imageable and curved in the direction of the side outlet opening through which the needle exits the catheter body. Thus, a radiographic image of the needle housing itself may be used (alone or in combination with the catheter's IVUS imaging capability) to guide and verify the positioning and rotational orientation of the catheter in situ to facilitate subsequent advancement of the needle into the true lumen rather than to some other undesired location. Moreover, the needle housing is sufficiently rigid and configured to provide support for the needle when the needle is in its advanced position.
There remains a need in the art for the development of new catheter devices and methods that may be used for re-entering the true lumen of an artery from a subintimal space and/or for other applications where a catheter is positioned in a natural or man-made body passage and it is desired to extend or advance a laterally deployable member from the catheter to some target location outside of the body passage within which the catheter is positioned.